Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study
12. května 2026 aktualizováno: Cook Children's Health Care System
6-Hz Primed Low and High-Frequency Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Children With Cerebral Palsy: TMS-EEG Study
This project examines the use of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic approach to improve motor function in children with cerebral palsy (CP).
By applying 6-Hz primed low and high-frequency rTMS and measuring brain responses through TMS-EEG, the study aims to enhance neural plasticity and motor recovery.
The goal is to promote faster rehabilitation and reduce long-term healthcare needs.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
Cerebral Palsy (CP) is a neurodevelopmental condition marked by motor impairments that affect both upper and lower limbs.
This project investigates the therapeutic benefits, safety, and tolerability of repetitive transcranial magnetic stimulation (rTMS) for improving motor function and meta-plasticity (re-organization) in children with CP.
Specifically, the study investigates the effects of 6-Hz primed low and high-frequency rTMS on neural motor function and meta-plasticity, utilizing TMS-EEG as a core method for assessing motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
Through modulating cortical excitability, the investigators expect that 6-Hz primed low and high-frequency rTMS will improve motor function and generate meta-plasticity in children with CP.
This improvement in motor and induced meta-plasticity potentially leads to faster rehabilitation outcomes and reduced need for long-term care, which would benefit both patients and hospital systems by lowering treatment costs and improving resource allocation.
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Behnam Ghabel Damirchi, MSc
- Telefonní číslo: 682-367-3956
- E-mail: behnam.ghabeldamirchi@cookchildrens.org
Studijní záloha kontaktů
- Jméno: Christos Papadelis, PhD
- Telefonní číslo: 682-305-3236
- E-mail: Christos.Papadelis@cookchildrens.org
Studijní místa
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Texas
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Fort Worth, Texas, Spojené státy, 76107
- Cook Children's Hospital
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Kontakt:
- Dr. Christos Papadelis, PhD, PhD
- Telefonní číslo: 682-305-3236
- E-mail: Christos.Papadelis@cookchilrens.org
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Dílčí vyšetřovatel:
- Behnam G Ghabel Damirchi, MSc
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria (CP):
- Aged 6 - 20 years,
- A confirmed diagnosis of CP by a specialized professional (pediatric neurologist, PM&R physician, neonatal developmental specialist, or neonatologist) is a prerequisite for participation,
- Classified as high functioning (Level I, II, or III) according to the Gross Motor Function Classification System (GMFCS),
- Age-appropriate ability to understand and comply with study procedure throughout the entire duration of the study,
- Preserved vision and hearing (with or without correction).
Inclusion Criteria (TD):
- Aged 6 - 20 years
- Age-appropriate ability to understand and comply with study procedure throughout the entire duration of the study,
- Preserved vision and hearing (with or without correction).
Exclusion Criteria (CP):
- Syndromic or genetic brain-related associations,
- History of major trauma or brain surgery,
- Inability to remain still,
- History of Epilepsy,
- Severe coexisting sickness or illness unrelated to CP or unstable medical conditions such as pneumonia,
- Modified Ashworth Scale: Shoulder, elbow, and wrist scores more than 3,
- Limb contractures caused by any other injury except CP,
- Severe movement disorders that prevent intentional limb movements, such as choreoathetosis, or ballismus,
- Contraindications for rTMS include non-removable metallic objects close to a coil and implanted electronic devices, such as cochlear implants and pacemakers.
Exclusion Criteria (TD):
- Syndromic or genetic brain-related associations,
- History of major trauma or brain surgery,
- Inability to remain still,
- History of Epilepsy,
- Severe coexisting sickness or illness unrelated to CP or unstable medical conditions such as pneumonia,
- Limb contractures caused by injury,
- Severe movement disorders that prevent intentional limb movements, such as choreoathetosis, or ballismus,
- Contraindications for rTMS include non-removable metallic objects close to a coil and implanted electronic devices, such as cochlear implants and pacemakers.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Intervention Group 1
CP participants in the experiment intervention group 1 will receive rTMS using a figure-of-eight-shaped coil and rTMS stimulator (Nexstim, Finland) targeting the contralesional primary motor cortex.
The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks.
Each session will begin with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses.
This will be followed immediately by 10 minutes of 1-Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 600 low-frequency pulses.
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All participants will undergo an MRI scan prior to the intervention to acquire T1-weighted images.
MRI data will be provided by the Cook Children's Radiology Department.
MRI scans will be used for neuronavigation.
rTMS is a safe, non-invasive way to map brain activity using gentle magnetic pulses.
A small coil is placed near the head to stimulate nerve cells without any pain.
This helps us understand how the brain controls movement.
High-density EEG (HD-EEG) is a safe and non-invasive brain imaging technique.
It involves placing a cap with small sensors on the child's head to measure the brain's electrical activity.
This technique does not send any energy into the brain.
The investigators will use the HD-EEG to measure motor-evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
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Experimentální: Intervention Group 2
CP Participants in experiment intervention group 2 will receive rTMS targeting the ipsilesional primary motor cortex.
The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks.
Each session will start with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses.
This will be followed immediately by 10 minutes of 10 Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 2000 high-frequency pulses.
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All participants will undergo an MRI scan prior to the intervention to acquire T1-weighted images.
MRI data will be provided by the Cook Children's Radiology Department.
MRI scans will be used for neuronavigation.
rTMS is a safe, non-invasive way to map brain activity using gentle magnetic pulses.
A small coil is placed near the head to stimulate nerve cells without any pain.
This helps us understand how the brain controls movement.
High-density EEG (HD-EEG) is a safe and non-invasive brain imaging technique.
It involves placing a cap with small sensors on the child's head to measure the brain's electrical activity.
This technique does not send any energy into the brain.
The investigators will use the HD-EEG to measure motor-evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
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Falešný srovnávač: Sham Group
CP participants in the sham group will receive sham rTMS by positioning the coil perpendicular to the scalp without delivering active stimulation, targeting both the contralesional and ipsilesional primary motor cortex.
The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks.
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All participants will undergo an MRI scan prior to the intervention to acquire T1-weighted images.
MRI data will be provided by the Cook Children's Radiology Department.
MRI scans will be used for neuronavigation.
rTMS is a safe, non-invasive way to map brain activity using gentle magnetic pulses.
A small coil is placed near the head to stimulate nerve cells without any pain.
This helps us understand how the brain controls movement.
High-density EEG (HD-EEG) is a safe and non-invasive brain imaging technique.
It involves placing a cap with small sensors on the child's head to measure the brain's electrical activity.
This technique does not send any energy into the brain.
The investigators will use the HD-EEG to measure motor-evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
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Aktivní komparátor: Control Group
Typically developed control group will complete a single baseline TMS-EEG session to measure TEPs.
This involves high-density EEG recording during single-pulse TMS to assess cortical excitability.
The session will last approximately 60-90 minutes.
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All participants will undergo an MRI scan prior to the intervention to acquire T1-weighted images.
MRI data will be provided by the Cook Children's Radiology Department.
MRI scans will be used for neuronavigation.
High-density EEG (HD-EEG) is a safe and non-invasive brain imaging technique.
It involves placing a cap with small sensors on the child's head to measure the brain's electrical activity.
This technique does not send any energy into the brain.
The investigators will use the HD-EEG to measure motor-evoked potentials (MEPs) and TMS-evoked potentials (TEPs).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change on TMS-evoked potentials (TEPs)
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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TEPs refer to the electrical responses in the brain elicited by rTMS.
This technique involves applying magnetic pulses to specific brain areas, which induce electrical activity that can be recorded using EEG.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change on cortical excitability - motor evoked potentials (MEPs)
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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MEPs are electrical signals generated by stimulating the brain's motor cortex and recorded from muscles.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Modified Ashworth Scale (MAS)
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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The Modified Ashworth Scale assesses spasticity in patients with central nervous system lesions or neurological disorders.
It provides a rapid and straightforward method for clinicians to evaluate spasticity while performing passive soft-tissue stretches.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Mirror Movement Assessment
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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This evaluates the presence and severity of involuntary mirror movements, where movement in one limb is mirrored by involuntary movement in the opposite limb.
It provides a structured approach to quantify and monitor these movements, helping to gauge the impact of therapeutic interventions and track changes over time.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Gross Motor Function Measure (GMFM-88)
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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It is a standardized observational tool specifically created and validated to assess changes in gross motor function over time in children with CP.
The GMFM-88 allows for the summation of item scores to generate raw and percentage scores for each of the five GMFM dimensions, the selected goal areas, and an overall GMFM-88 score.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Adverse effects
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Adverse effects of TMS-EEG can include temporary headaches, scalp discomfort, and mild skin irritation from EEG electrodes.
Rarely, individuals might experience transient cognitive effects or muscle twitching.
There is also a minimal risk of inducing seizures, particularly in those with a history of epilepsy.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Finger Tapping Task
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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A keyboard tapping task measuring low-level motor ability and psychomotor speed.
Modeled after the Finger Tapping or Oscillation task from the Reitan Test Battery.
Participants tap a key as quickly as possible for multiple trials, testing dominant and/or non-dominant hand.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Task Fitt's Law Task
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Classic motor control task measuring the speed-accuracy tradeoff in rapid aimed movements.
Tests the relationship between movement time, distance, and target size, following Fitts' Law (MT = a + b*log2(2D/W)).
Participants rapidly move the mouse cursor from a home position to rectangular targets of varying sizes and distances.
Each trial begins at the home position on the left side of the screen.
When ready, participants move to the target rectangle as quickly as possible.
Movement time and accuracy are recorded for each trial.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Pursuit Rotor
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Motor tracking task requiring continuous tracking of a moving target with mouse or touch input.
Measures motor coordination and learning.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Time Tapping Task
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Motor timing task measuring self-paced tapping consistency across multiple trials.
Participants tap at a self-paced even rate following a visual entrainment period.
After seeing a flashing cross that demonstrates the target tapping rate, participants must maintain that rhythm for a sustained period (default 180 seconds per trial).
The task assesses low-level motor timing ability and may be sensitive to fatigue, sleep deprivation, and motor control deficits.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Simple Reaction Time
Časové okno: Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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A simple reaction time task where a single stimulus (an 'X' or mouse button prompt) appears at a specifiable delay from the previous response.
Measures basic alertness and motor response speed across multiple blocks with breaks.
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Within the end of 4 weeks and 1-month follow-up of sham/real rTMS
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Christos Papadelis, PhD, Cook Children's Health Care System
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. května 2026
Primární dokončení (Odhadovaný)
1. května 2028
Dokončení studie (Odhadovaný)
1. června 2030
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
28. dubna 2026
První zveřejněno (Aktuální)
5. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Dětská mozková obrna
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Kahramanmaras Sutcu Imam UniversityNáborCerebral Palsy Gmfcs-er i-iiTurecko (Türkiye)
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Clene NanomedicineNational Institute of Neurological Disorders and Stroke (NINDS)Dočasně nedostupnéAmyotrofní laterální skleróza | ALS | PALSSpojené státy
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Lund UniversityNáborDěti s dětskou mozkovou obrnou, které jsou ambulantní | Cerebral Palsy Gmfcs-er i-iiŠvédsko
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Auckland City HospitalThe University of Queensland; Auckland Medical Research Foundation; The Australian... a další spolupracovníciAktivní, ne náborMrtvice | Krevní tlak | Embolus CerebralAustrálie, Nový Zéland
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University of New MexicoUniversity of California, San FranciscoUkončenoCerebrální kavernózní malformaceSpojené státy
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Recursion Pharmaceuticals Inc.DokončenoCerebrální kavernózní malformaceSpojené státy
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Mario Negri Institute... a další spolupracovníciNáborFamiliární cerebrální kavernózní malformace | CCMItálie
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University of California, San FranciscoUniversity of Chicago; National Institute of Neurological Disorders and Stroke... a další spolupracovníciAktivní, ne náborMozkové kavernózní malformace | Cavernózní angiom, familiární | Mozkový kavernózní hemangiomSpojené státy
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University of ChicagoMayo Clinic; National Institute of Neurological Disorders and Stroke (NINDS); University of California, San Francisco a další spolupracovníciAktivní, ne náborCerebrální kavernózní malformace | Cavernózní angiom | Hemoragická mikroangiopatieSpojené státy
Klinické studie na MRI
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Seoul National University Bundang HospitalBayerDokončenoTraumaKorejská republika
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Cambridge University Hospitals NHS Foundation TrustNáborRakovina prsuSpojené království
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)UkončenoOsteosarkom | Ewingův sarkom | Pagetova nemocSpojené státy
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American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupNeznámýRakovina prsu | BIRADS 3 | BIRADS 4 | BIRADS 5Spojené státy
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University of EdinburghDokončeno
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Assistance Publique - Hôpitaux de ParisNeznámýPoranění mozku, kóma | Srdeční zástava (CA) | Traumatické poranění mozku (TBI) | Aneuryzmatické subarachnoidální krvácení (aSAH)Francie
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Sheba Medical CenterNeznámý
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Assistance Publique Hopitaux De MarseilleAktivní, ne náborRoztroušená sklerózaFrancie
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Assistance Publique Hopitaux De MarseilleDokončenoAmyotrofní laterální sklerózaFrancie
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Medical University of ViennaDokončenoNeuropatie brachiálního plexu | Traumatická léze brachiálního plexu | Bionická rekonstrukce rukyRakousko